IVIV correlation.pptx
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This document summarizes a seminar presentation on IVIV correlation and biowaiver considerations. It defines IVIV as establishing a relationship between an in vitro property (e.g. drug dissolution rate) and an in vivo response (e.g. plasma drug concentration). It discusses the different levels of IVIV correlation from A to C and their meaning. It also covers parameters used for correlation, purposes of IVIV including reducing regulatory burden and justification for product quality, and biowaiver considerations when in vivo studies can be substituted with in vitro data.
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IVIVC
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3) The main purposes of IVIVC include reducing regulatory burden by substituting for human studies, optimizing formulations, justifying product quality, and supporting waivers for post-approval changes based on in vitro dissolution tests.
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The document discusses in vitro-in vivo correlation (IVIVC), which aims to establish a relationship between a drug product's in vitro dissolution or release characteristics and the corresponding in vivo response. It covers topics like the importance of IVIVC, factors that affect its development, different levels of correlation, methods for establishing correlation, and applications. The overall goal of IVIVC is to use in vitro dissolution testing to predict in vivo bioavailability and performance of drug products.
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United State Pharmacopoeia (USP)
The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA)
IVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
The main objective of developing and evaluating an IVIVC is to enable the
dissolution test to serve as a surrogate (alternate) for in vivo bioavailability studies in
human beings.
The applications of developing such an IVIVC are —
1. To ensure batch-to-batch consistency in the physiological performance of a drug
product by use of such in vitro values.
2. To serve as a tool in the development of a new dosage form with desired in vivo
performance.
3. To assist in validating or setting dissolution specifications (i.e. the dissolution
specifications are based on the performance of product in vivo).
There are two basic approaches by which a correlation between dissolution testing
and bioavailability can be developed:
1. By establishing a relationship, usually linear, between the in vitro dissolution and
the in vivo bioavailability parameters.
2. By using the data from previous bioavailability studies to modify the dissolution
methodology in order to arrive at meaningful in vitro-in vivo correlation.
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This document provides an overview of in vitro/in vivo correlations (IVIVCs). It discusses the importance of establishing relationships between in vitro dissolution characteristics and in vivo bioavailability. The document outlines a systematic approach to developing IVIVCs, including initial assumed models, retrospective models based on early studies, and prospective models established through defined studies. It also discusses factors that can affect IVIVC development and describes three stages of product development where IVIVCs can be utilized.
correlation of invivo data with invitro dissolution data.pptx
This document discusses the correlation of in vivo drug data with in vitro dissolution data. It begins by defining in vitro-in vivo correlation (IVIVC) as a predictive mathematical model relating an in vitro property like dissolution rate to an in vivo response like plasma drug concentration. The objectives of IVIVC include reducing human testing and regulatory burdens. There are different levels of IVIVC - Level A provides the closest correlation while Level D is only qualitative. Level A correlates dissolution directly to absorption rate while Level C relates a parameter like AUC to a dissolution parameter. IVIVC can be used to justify formulation and process changes without additional human studies.
IVIVC
It is defined as “the predictive mathematical model that describes the relationship between in vitro property (such as rate & extent of dissolution) of a dosage form and in vivo response (such as plasma drug concentration or amount of drug absorbed)”.
Iviv corelation
This document discusses in vitro-in vivo correlations (IVIVC), which relate the dissolution of a drug from its dosage form in vitro to its bioavailability or absorption rate in vivo. It defines IVIVC and explains its significance in reducing bioequivalence studies. The key parameters that can be correlated are discussed, including dissolution rate versus absorption rate, percent dissolved versus percent absorbed, and percent dissolved versus pharmacokinetic parameters. The different levels of IVIVC - Level A, B, and C - are outlined. A case study example of developing a Level A IVIVC for leflunomide microspheres is provided. In conclusion, the current focus is on validating Level A correlations and further research is needed
In vitro In vivo correlation.pptx
An in vitro – in vivo correlation (IVIVC) is defined as a predictive mathematical model describing the relationship between the in vitro property of an oral dosage form and relevant in vivo response.
In Vitro In vivo Correlation
This document discusses in vitro-in vivo correlation (IVIVC) which aims to establish a relationship between a drug product's in vitro dissolution profile and its in vivo performance. It defines IVIVC and describes the different levels (A, B, C) based on the strength of correlation. A Level A correlation allows using the in vitro dissolution curve as an alternative to in vivo studies for quality control. It is the most informative for regulatory purposes. Level B uses mean dissolution time comparisons while Level C correlates a single dissolution time point to a pharmacokinetic parameter.
In vitro-in-vivo-studies
This document provides details on establishing in vitro-in vivo correlations (IVIVC) for drug products. It discusses the need for and importance of IVIVCs, including reducing human studies, serving as a surrogate for in vivo bioavailability, and assisting with quality control. The document outlines the objectives and purposes of IVIVCs, as well as factors that can affect developing a predictable IVIVC. It also describes different types and levels of correlations and provides a case study example. Overall, the document provides a comprehensive overview of establishing IVIVCs to correlate in vitro dissolution tests to in vivo performance of drug products.
Four Levels of In-Vitro-In-Vivo Correlation
1) There are four levels of in vitro-in vivo correlations (IVIVC) ranging from Level A to Level D. Level A correlation involves point-to-point correlation of dissolution and absorption profiles and is most useful for regulatory purposes. Level B uses statistical moments, while Level C correlates single dissolution timepoints to pharmacokinetic parameters.
2) The document discusses a case study developing a Level A IVIVC for a prolonged-release hydrocodone formulation. Dissolution and pharmacokinetic profiles from clinical studies were used to establish a direct correlation between % dissolved and % absorbed using linear and nonlinear time scaling.
3) The Level A IVIVC showed good predictability of less than 10%
IN-VITRO AND IN-VIVO CORRELATIONS.pptx
This document provides an overview of in-vitro and in-vivo correlations (IVIVC). It defines IVIVC and discusses the different levels of correlation from A to D. It also covers the biopharmaceutical classification system and how IVIVC expectations differ for different drug classes. Key factors that affect IVIVC are described. Applications of IVIVC in drug delivery include using it to set dissolution specifications and support biowaivers. In summary, IVIVC provides a link between in-vitro dissolution testing and in-vivo bioavailability, which has important applications in drug development and regulation.
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correlation of invivo data with invitro dissolution data.pptx
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IVIV correlation.pptx
- 1. A SEMINAR ON Topic: IVIV Correlation & Biowaiver Considerations Presented By: Hariom Jaiswal (2101200566005) M. Pharm (Pharmaceutics) 1st Year / 2st Sem (2021-22) INSTTITUTE OF TECHNOLOGY OF MANAGEMENT GIDA, GORAKHAPUR, U.P
- 2. CONTENTS: Introduction of IVIV Definition of IVIV Purpose of IVIV Parameters used for Correlating in IVIV Level of IVIV Biowaiver Considerations References
- 3. Introduction of IVIV: IVIV plays an critical role in drug development and in optimization of formulation which is certainly a time consuming and expensive process. IVIV allow dosage form optimization with the fewest possible trail in man, fixes dissolution acceptance for further bioequivalence studies.
- 4. Definition of IVIV: As per USP:- The establishment of rational relationship between a biological property, or parameter derived for biological property produced by dosage form, and a physiochemical property or characteristic of dosage form. As per FDA:- A predictive mathematical model describing relationship between an IN- VITRO property of dosage form and IN-VIVO response. • Generally, In-Vitro property is rate and extend of drug dissolution or release while the In-Vivo response in plasma drug concentration or amount of drug absorbed.
- 5. Purpose of IVIV: Reduction of regulatory burden. Optimization of formulation. Justification for therapeutic product quality. SUPAC (Scale Up and Post Approval Changes. To minimize the unnecessary human testing. Minimizing the cost and time required in the additional bioavailability studies.
- 6. Parameters used for Correlating in IVIV: In Vitro Parameters Time for a specific amount dissolved Amount dissolved a specific a time point Mean dissolution In Vivo Parameters Area under the conc. Vs time curve Fraction absorbed, absorption rate constant Mean residence time
- 7. Correlation Level of IVIV: There are 5 types of levels described in FDA guideline which include. • Level A • Level B • Level C • Multiple level C
- 8. Level- A: Highest Category of correlation. Linear correlation. Superimposable In Vitro and In Vivo input curve or can be superimposable by use of a constant offset value. Most informative and useful form a regulatory perspective.
- 9. Level-B: Uses the principles of statistical moment analysis. The mean In Vitro dissolution time is compared either to the mean residence time (MRT) or to the mean In Vivo dissolution time. Is not a point to point correlation. Level B correlations are rarely seen in NDAs.
- 10. Level-C: Level C correlation represent a single point correlation. One dissolution time point (t50%, t90%, etc.) is compared to one mean pharmacokinetics parameter such as AUC , Tmax & Cmax. Weakest level of correlation as partial relationship between absorption and dissolution is established.
- 11. Multiple Level –C Correlation: It is relates one or several pharmacokinetic parameter of interest to the amount of drug dissolved at several time points of the dissolution profile. Its correlation is more meaningful than that of Level- C as several time points are considered.
- 12. Biowaiver Consideration: Its refers to the situations in which In Vivo BE studies can be substituted with the relevant In Vitro data. Most common type of biowaiver adopted by the regulatory authorities includes the application of the BCS- based scheme or the application of IVIV. According to the FDA, biowaivers for IR drug products may be requested in solely in the cases of highly soluble and highly permeable substances when the drug product is very rapidly dissolving and exhibits similar dissolution profile to the reference product, while the IVIV- based approach has been narrowed down to application for XR products.
- 13. References: Computer Application in Pharmaceutical Research and Development, Sean Ekins, 2006 John Wiley & Sons. https://www.slideshare.net/MOHDIMRAN139/ivivc- 87394566 https://www.slideshare.net/Zahid1392/iv-dissolution- iviv-corelation https://www.slideshare.net/ANUSHANADIKATLA/in -vitro-in-vivo-correlation-122984972